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Pace® Labs · 1 day ago

Senior Regulatory Affairs Specialist (Remote)

United States

Full-time

Remote

Senior Level, Lead/Staff

$150K/yr - $175K/yr

10+ years exp

Pace® Labs is dedicated to advancing health and safety through science, and they are seeking a Senior Regulatory Affairs Specialist to lead and execute global regulatory strategies. The role involves ensuring compliance with regulatory requirements for investigational and marketed products, serving as a strategic advisor to clients, and optimizing business outcomes.

Executive Office

Responsibilities

Regulatory Submissions: Author and compile CMC sections of regulatory applications, including INDs, IMPDs, CTAs, amendments, and annual reports

Documentation: Draft and maintain high-quality CMC regulatory documents such as Module 2 and 3 summaries, stability reports, and comparability protocols

Communication: Support regulatory interactions by preparing responses to CMC-related questions from FDA, EMA, PMDA, and other global health authorities

Strategy Implementation: Prepare and Lead Regulatory interactions for CMC regulatory strategies to support clinical trial initiation and advancement

Process Development: Contribute to the development of templates, processes, and workflows to support efficient and compliant CMC regulatory operations

Other duties as assigned

Qualification

CMC regulatory experienceRegulatory submissionsGlobal regulatory knowledgeRegulatory document managementTechnical writingManage timelinesOrganizational skillsCommunication skillsAttention to detail

Required

B.A. / B.A./ M.S. / Ph.D. in biochemistry, chemistry, biology, or related pharmaceutical field with a minimum of 10+ years of experience in CMC /regulatory affairs

Hands-on experience authoring and compiling CMC sections of INDs, IMPDs, CTAs, amendments, and related filings

Strong knowledge of global CMC clinical regulatory requirements and guidelines, including FDA, EMA, and ICH

Excellent attention to detail, technical writing, organizational, and communication skills

Ability to manage multiple deliverables and timelines in a fast-paced environment

Proficiency with regulatory document management systems